IMMX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• In December 2025, we announced positive interim phase 2 safety and efficacy data from our Phase1/2 NEXICART-2 clinical trial, the first U.S. trial of CAR-T in relapsed/refractory light chain AL, evaluating NXC-201. The results were as of November 13, 2025 and were presented by Heather Landau, MD, of…

• In January 2026, the FDA granted Breakthrough Therapy designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious conditi…

• After NXC-201 treatment, complete responses (“CRs”) were observed in 75% (at s/u IFE(-) level) (15 out of 20) patients as determined by an independent review committee. In four out of five pending patients, minimum residual disease (MRD) negativity in bone marrow suggests a future complete response …

• Our other programs include NXC-201 for treatment of select other serious diseases and other preclinical candidates.

• Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our Company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the…

相对上期删除的文字 · 来源:10-Q · 2025-11-07

• NXC-201 is in clinical trials to treat relapsed/refractory AL Amyloidosis.

• As of October 2025, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.

• The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal 2021, estimated to reach 37,270 patients in 2025. Untreated patients with AL amyloidosis and cardiac involvement have a median survival of less than 1 year, acco…

• As of October 2025, we have disclosed treatment of 10 relapsed/refractory AL Amyloidosis patients in the United States in our ongoing Phase 1b/2 multi-site NEXICART-2 (NCT06097832) U.S. clinical trial. Memorial Sloan Kettering Cancer Center is the lead NEXICART-2 clinical site.

• As of October 2025, we have disclosed treatment of 16 relapsed/refractory AL Amyloidosis patients in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) ex-U.S. clinical trial.

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-07

• Material Weakness in Internal Controls Over Financial Reporting

• We identified a material weakness in our internal control over financial reporting that existed as of December 31, 2024, as discussed in greater detail in “Item 9A. Controls and Procedures” of the 2024 Form 10-K. A material weakness is a deficiency, or a combination of deficiencies, in internal cont…

• Notwithstanding the material weaknesses in our internal control over financial reporting, we have concluded that the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of operations and …

• With the oversight of senior management, we continue to work to remediate our material weaknesses, including the establishment of additional points of segregation of duties across our key processes and the upgrade of our information technology general controls. We will continue to evaluate and imple…

• Inherent Limitations on Effectiveness of Controls and Procedures

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• Rule 10b5-1 Trading Plans. During the quarter ended March 31, 2026, none of the Company’s directors or officers (as defined in Rule 16a-1(f)) adopted or terminated any contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative de…

相对上期删除的文字 · 来源:10-Q · 2025-11-07

• (a) The below events occurred within four business days of the filing date of this periodic report and as such, the Company is disclosing the occurrence of the events under Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arra…

• Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

• Effective on November 3, 2025, the Board of Directors of the Company, with the recommendation of the Compensation Committee of the Board of Directors of the Company, agreed to clarify and amend each of the prior outstanding options of the Company granted under the Company’s 2021 Omnibus Equity Incen…

• Such amendments are subject in all cases to the entry by the Company into first amendment to stock option grant notice and option agreements with each option holder, which the Company expects to have completed in the next several days.

• (c) Rule 10b5-1 Trading Plans. During the quarter ended September 30, 2025, none of the Company’s directors or officers (as defined in Rule 16a-1(f)) adopted or terminated any contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirm…